* Single dose unless otherwise noted.

† Percent change (with/without coadministered drug and no change=0%); ↑ and ↓ indicate the exposure increase and decrease, respectively.

‡ AUC=AUC(INF) for drugs given as single dose and AUC=AUC(TAU) for drugs given in multiple doses.

In Vitro Assessment of Drug Interactions

Saxagliptin

The metabolism of saxagliptin is primarily mediated by CYP3A4/5.

In in vitro studies, saxagliptin and its active metabolite did not inhibit CYP1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, or 3A4, or induce CYP1A2, 2B6, 2C9, or 3A4. Therefore, saxagliptin is not expected to alter the metabolic clearance of coadministered drugs that are metabolized by these enzymes. Saxagliptin is a P-glycoprotein (P-gp) substrate, but is not a significant inhibitor or inducer of P-gp.

In Vivo Assessment of Drug Interactions

Effects of Other Drugs on Saxagliptin and its Active Metabolite, 5-hydroxy Saxagliptin

Table 5. Effect of Coadministered Drugs on Systemic Exposures of Saxagliptin and its Active Metabolite, 5-hydroxy Saxagliptin

ND=not determined; QD=once daily; q6h=every 6 hours; q12h=every 12 hours; BID=twice daily; LA=long acting.

* Single dose unless otherwise noted.

† AUC=AUC(INF) for drugs given as single dose and AUC=AUC(TAU) for drugs given in multiple doses.

‡ Results exclude one subject.

§ The plasma dipeptidyl peptidase-4 (DPP-4) activity inhibition over a 24-hour dose interval was not affected by rifampin.

¶ Percent change (with/without coadministered drug and no change=0%); ↑ and ↓ indicate the exposure increase and decrease, respectively.

Effects of Saxagliptin on Other Drugs

Table 6. Effect of Saxagliptin on Systemic Exposures of Coadministered Drugs

ND=not determined; QD=once daily; q6h=every 6 hours; q12h=every 12 hours; BID=twice daily; LA=long acting.

* Single dose unless otherwise noted.

† AUC=AUC(INF) for drugs given as single dose and AUC=AUC(TAU) for drugs given in multiple doses.

‡ Results include all subjects.

§ Percent change (with/without coadministered drug and no change=0%); ↑ and ↓ indicate the exposure increase and decrease, respectively.

13. HOW SUPPLIED/STORAGE AND HANDLING 

How Supplied:

QTERN (dapagliflozin and saxagliptin) tablets for oral use are available in packages as listed:

10 mg dapagliflozin / 5 mg saxagliptin: Light brown to brown, biconvex, round tablet, “1122” printed on one side, in blue ink.

Bottles of 30: NDC 0310-6780-30

Bottles of 90: NDC 0310-6780-90

Bottles of 500: NDC 0310-6780-50

Storage and Handling:

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].